Back to resultsIntensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study (D-CARE)
Primary Purpose
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Prochaska and DiClemente transtheorical model
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Self Management, Behavior, Type 2 Diabetes Mellitus, Cardiovascular Disease
Eligibility Criteria
Inclusion Criteria: Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis); To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization; Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation; T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.); Exclusion Criteria: Pregnant women; People living with HIV/AIDS; T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia; T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization; T2DM patients with severe eye and retine disease; Patients participating in another study simultaneously; Patients living with others in the same place.
Sites / Locations
- Universidade do Extremo Sul Catarinense
- Universidade do Extremo Sul CatarinenseRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Behavior-changing/Self-Management
Usual Care
Arm Description
This arm is composed by group-based interventions aiming to modify the self-management of the patients through the Prochaska and DiClemente transtheorical model. It is composed by weekly meetings, lasting up to 1 hour and a half, targeting eight patients per group. After the 12nd month of intervention, the meetings will be held each fifteen days untill the trial ending (18 months). The meetings will deal with lifestyle matters, such as nutrition, weight management, and physical activity, as well as medication adherence, blood glucose testing, and others. Whenever a care provider will be assigned to a group, he/she will go over untill the final of the trial, unless unexpected motivations appear. Patients achieving maintenance will receive green flag from the group-based interventions to avoid contamination. It is up to the care provider to perceive the readiness of the patient to another stage.
Patients randomized to the usual care group will follow the same schedule of the experimental group for outcome assessment; however, the trial team will not intervene in the group - i.e., the group will continue their care routine in their primary care unit.
Outcomes
Primary Outcome Measures
Glycemic control
Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)
Secondary Outcome Measures
Blood Pressure control
Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)
All-cause number of health care settings visits
All-cause number of health care settings visits measured by counts
Attributable number of health care settings visits to type 2 diabetes mellitus
Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts
Weight
Anthropometric variables measured in kg
Height
Anthropometric variables -measured in meters
Body mass index
Anthropometric variables - kg per square meter
Abdominal circumference
Anthropometric variables - measured in centimeters (cm)
Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form
There are three levels of physical activity suggested for classifying populations; these are the new proposed levels, which take account of the concept of total physical activity of all domains. The proposed levels are: inactive; minimally active and HEPA activeí health-enhancing physical activity; a highly active category
Depression scores by Hamilton Depression Rating Scale - HDR-S
A score of 0-7 is generally accepted to be within the normal range (or in clinical emission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil
Qualitative assessment of food intake for the previous day.
Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs
Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients
Low density lipoprotein levels - LDL-C
Serum LDL-C levels in mg/dL
High density lipoprotein levels - HDL-C
Serum HDL-C levels in mg/dL
Total cholesterol levels - TC
Serum TC levels in mg/dL
Total triglycerides levels - TG
Serum TG levels in mg/dL
Creatinine levels
Serum creatinine levels in mg/dL
Diabetes Mellitus knowledge (DKN-A)
The measuring scale used is from 0 to 15. A score of one (1) is attributed to the correct answer and of zero (0) for the incorrect answer. A score higher than eight (8) indicates knowledge about diabetes mellitus
Diabetes Attitude Questionnaire (ATT-19)
ATT-19 is an instrument that seeks to measure psychological adjustment for diabetes mellitus, developed in response to the need for evaluation of the psychological and emotional aspects of the disease. It contains nineteen items that include six factors: a) DM-associated stress, b) treatment receptivity, c) trust in the treatment, d) personal efficiency, e) health perception, and f) social acceptance, with the answers measured using a five-point Likert scale (completely disagree - score 1; up to completely agree - score 5). The total value of the score can vary from 19 to 95 points. A score higher than 70 indicates a positive attitude toward the disease. In this instrument, attitude is related to the decision of the individual to adopt or not the self-care measures for diabetes control.
Full Information
NCT ID
NCT05969015
First Posted
July 10, 2023
Last Updated
July 21, 2023
Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Prefeitura Municipal de Criciúma, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS), Hospital Universitário São José
1. Study Identification
Unique Protocol Identification Number
NCT05969015
Brief Title
Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study
Acronym
D-CARE
Official Title
Educação em saúde Intensiva na atenção primária à saúde em Pacientes Com Diabetes Mellitus Tipo 2: um Ensaio clínico Randomizado - The Diabetes Care (D-CARE) Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidade do Extremo Sul Catarinense - Unidade Academica de Ciecias da Saude
Collaborators
Prefeitura Municipal de Criciúma, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Departamento de Promoção da Saúde (DEPROS), Secretaria de Atenção Primária à Saúde (SAPS), Hospital Universitário São José
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Type 2 diabetes mellitus (T2DM) leads to a high burden of morbidity and mortality, usually attributable to cardiovascular (CVD) causes. A major concern about the disease is that the success of the treatment is highly dependent on self-management, which very often incurs the necessity of behavior change. However, modifying such behaviors, usually linked to daily-life activities, is challenging. Then, the investigators aimed to test the optimal self-management that could be achieved in a reasonable manner carried forward through the Prochaska and DiClemente behavior-changing strategy in a follow-up of 18 months, compared to usual care. Our primary outcome is the between-group difference in HbA1c (%) levels.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Cardiovascular Diseases, Diabetes Mellitus
Keywords
Self Management, Behavior, Type 2 Diabetes Mellitus, Cardiovascular Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is an effectiveness/pragmatic, parallel-arm, randomized, superiority trial.
Masking
Outcomes Assessor
Masking Description
Outcomes' assessors will be masked to assigned interventions in all measurements they would perform.
Allocation
Randomized
Enrollment
384 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavior-changing/Self-Management
Arm Type
Experimental
Arm Description
This arm is composed by group-based interventions aiming to modify the self-management of the patients through the Prochaska and DiClemente transtheorical model. It is composed by weekly meetings, lasting up to 1 hour and a half, targeting eight patients per group. After the 12nd month of intervention, the meetings will be held each fifteen days untill the trial ending (18 months). The meetings will deal with lifestyle matters, such as nutrition, weight management, and physical activity, as well as medication adherence, blood glucose testing, and others. Whenever a care provider will be assigned to a group, he/she will go over untill the final of the trial, unless unexpected motivations appear. Patients achieving maintenance will receive green flag from the group-based interventions to avoid contamination. It is up to the care provider to perceive the readiness of the patient to another stage.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Patients randomized to the usual care group will follow the same schedule of the experimental group for outcome assessment; however, the trial team will not intervene in the group - i.e., the group will continue their care routine in their primary care unit.
Intervention Type
Behavioral
Intervention Name(s)
Prochaska and DiClemente transtheorical model
Intervention Description
The Prochaska and DiClemente model will be combined to a self-management program in patients with T2DM within 18 months. They will be classified accordingly to their readiness for changing. A care provider will manage the group towards an optimal self-management, aiming to improve their glycemic control and other outcomes of relevance. We will conduct 1 session per week until the end of 12nd intervention month. After, the sections will be conducted each 2 weeks until the end of the trial. Healthcare professional will provide support to the care provider. The recommended processes to progress the patients will be used to trigger them accordingly to their stage, at the discretion of the care provider. We will also consider individualities and non-anticipated problems as a part of the process of behavior changing.
Primary Outcome Measure Information:
Title
Glycemic control
Description
Glycemic control as measured by glycated haemoglobin (HbA1c) levels (%)
Time Frame
at 3-monthly intervals during 18 month
Secondary Outcome Measure Information:
Title
Blood Pressure control
Description
Blood Pressure control as measured by office systolic and diastolic blood pressure (SBP/DBP in mmHg)
Time Frame
at 6-monthly intervals during 18 month
Title
All-cause number of health care settings visits
Description
All-cause number of health care settings visits measured by counts
Time Frame
at 6-monthly intervals during 18 month
Title
Attributable number of health care settings visits to type 2 diabetes mellitus
Description
Attributable number of health care settings visits to type 2 diabetes mellitus measured by counts
Time Frame
at 6-monthly intervals during 18 month
Title
Weight
Description
Anthropometric variables measured in kg
Time Frame
at 6-monthly intervals during 18 month
Title
Height
Description
Anthropometric variables -measured in meters
Time Frame
at 6-monthly intervals during 18 month
Title
Body mass index
Description
Anthropometric variables - kg per square meter
Time Frame
at 6-monthly intervals during 18 month
Title
Abdominal circumference
Description
Anthropometric variables - measured in centimeters (cm)
Time Frame
at 6-monthly intervals during 18 month
Title
Physical activity levels - Guidelines for Data Processing and Analysis of the International Physical Activity Questionnaire (IPAQ) - Short Form
Description
There are three levels of physical activity suggested for classifying populations; these are the new proposed levels, which take account of the concept of total physical activity of all domains. The proposed levels are: inactive; minimally active and HEPA activeí health-enhancing physical activity; a highly active category
Time Frame
at 6-monthly intervals during 18 month
Title
Depression scores by Hamilton Depression Rating Scale - HDR-S
Description
A score of 0-7 is generally accepted to be within the normal range (or in clinical emission), while a score of 20 or higher (indicating at least moderate severity) is usually required for entry into a clinical trial.
Time Frame
at 6-monthly intervals during 18 month
Title
Anxiety scores - Hamilton Anxiety Rating Scale (HAM-A)
Description
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Time Frame
at 6-monthly intervals during 18 month
Title
MARKERS OF FOOD CONSUMPTION - Food and nutrition surveillance system - Brazil
Description
Qualitative assessment of food intake for the previous day.
Time Frame
at 6-monthly intervals during 18 month
Title
Number of hypoglycemiants, anti-hypertensives and hypolipidemic drugs
Description
Count of hypoglycemiants, anti-hypertensives and hypolipidemic drugs taken by patients
Time Frame
at 6-monthly intervals during 18 month
Title
Low density lipoprotein levels - LDL-C
Description
Serum LDL-C levels in mg/dL
Time Frame
at 3-monthly intervals during 18 month
Title
High density lipoprotein levels - HDL-C
Description
Serum HDL-C levels in mg/dL
Time Frame
at 3-monthly intervals during 18 month
Title
Total cholesterol levels - TC
Description
Serum TC levels in mg/dL
Time Frame
at 3-monthly intervals during 18 month
Title
Total triglycerides levels - TG
Description
Serum TG levels in mg/dL
Time Frame
at 3-monthly intervals during 18 month
Title
Creatinine levels
Description
Serum creatinine levels in mg/dL
Time Frame
at 3-monthly intervals during 18 month
Title
Diabetes Mellitus knowledge (DKN-A)
Description
The measuring scale used is from 0 to 15. A score of one (1) is attributed to the correct answer and of zero (0) for the incorrect answer. A score higher than eight (8) indicates knowledge about diabetes mellitus
Time Frame
at 6-monthly intervals during 18 month
Title
Diabetes Attitude Questionnaire (ATT-19)
Description
ATT-19 is an instrument that seeks to measure psychological adjustment for diabetes mellitus, developed in response to the need for evaluation of the psychological and emotional aspects of the disease. It contains nineteen items that include six factors: a) DM-associated stress, b) treatment receptivity, c) trust in the treatment, d) personal efficiency, e) health perception, and f) social acceptance, with the answers measured using a five-point Likert scale (completely disagree - score 1; up to completely agree - score 5). The total value of the score can vary from 19 to 95 points. A score higher than 70 indicates a positive attitude toward the disease. In this instrument, attitude is related to the decision of the individual to adopt or not the self-care measures for diabetes control.
Time Frame
at 6-monthly intervals during 18 month
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Adverse Events as counts: all-cause mortality, cardiovascular mortality, STEMI and non-STEMI (fatal and non-fatal), heart failure diagnosis, unstable angina hospitalizations, cardiovascular procedures, hospital admission or re-admission, chronic kidney disease, retinopathy diagnosis, falls.
Time Frame
at 6-monthly intervals during 18 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Outpatients diagnosed with type 2 diabetes mellitus - T2DM (HbA1c % - ≥ 6.5%, or taking at least one oral hypoglycaemic agent, or medical diagnosis);
To be regularly assisted by the Sistema Único de Saúde and to have been saw at least one year before randomization;
Readiness for behavior-changing within the pre-action stages: pre-contemplation, contemplation and preparation;
T2DM patient of challenging handling (e.g., frequent hypoglycaemic seizures, cardiovascular disease (CVD), etc.);
Exclusion Criteria:
Pregnant women;
People living with HIV/AIDS;
T2DM patients taking erythropoietin, recent blood loss, recent blood transfusion and severe anaemia;
T2DM patients with CVD under non-optimized treatment; or those that made any CVD procedure; or CVD event (e.g., myocardial infarction) within three months before randomization;
T2DM patients with severe eye and retine disease;
Patients participating in another study simultaneously;
Patients living with others in the same place.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciane B Ceretta, PhD
Phone
+55 48 3431 2600
Email
luk@unesc.net
First Name & Middle Initial & Last Name or Official Title & Degree
Cristiane D Tomasi, PhD
Phone
+55 48 3431 2609
Email
cdtomasi@unesc.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Luciane B Ceretta, PhD
Organizational Affiliation
Universidade do Extremo Sul Catarinense, The D-CARE Coordinator Committee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cristiane D Tomasi, PhD
Organizational Affiliation
Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Vanessa IA Miranda, PhD
Organizational Affiliation
Universidade do Extremo Sul Catarinense, The D-CARE Coordinator/Steering Committee
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andriele Vieira, PhD
Organizational Affiliation
The D-CARE Steering Committee
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Felipe Dal-Pizzol, MD, PhD
Organizational Affiliation
Universidade do Extremo Sul Catarinense, The D-CARE Adjudication/Medical Committee
Official's Role
Study Director
Facility Information:
Facility Name
Universidade do Extremo Sul Catarinense
City
Criciúma
State/Province
Santa Catarina
ZIP/Postal Code
88806-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiane D Tomasi, PhD
Phone
+55 48 3431 2609
Email
cdtomasi@unesc.net
First Name & Middle Initial & Last Name & Degree
Vanessa IA Miranda, PhD
Phone
+55 48 3431 2609
Email
vanessairi@unesc.net
First Name & Middle Initial & Last Name & Degree
Luciane B Ceretta, PhD
First Name & Middle Initial & Last Name & Degree
Andriele Vieira, PhD
First Name & Middle Initial & Last Name & Degree
Felipe Dal-Pizzol, MD, PhD
Facility Name
Universidade do Extremo Sul Catarinense
City
Criciúma
State/Province
Santa Catarina
ZIP/Postal Code
88806000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andriele Vieira, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
We will work under individual participant data sharing policy in this study. Third parties interest in should contact the D-CARE Study staff. The IPD Data Sharing Statement is disclosed clearly to patients in our informed consent and also was approved by the responsible IRB. The data will be shared in a deidentified manner, altogether with dictionaries, glossaries, statistical/analytic codes and materials. Authors should provide a proposal that should include the merit, objectives, ethical duties and a data safety plan. For further details please contact the IPD data-sharing committee of the D-CARE Study.
IPD Sharing Time Frame
After 6 months after the release of the main report of the study up with no constraints in the upper limit.
IPD Sharing Access Criteria
Under the auspicious of the IPD and steering committee of the D-CARE Study.
Learn more about this trial
Intensive Self-care on Glycemic Control in Outpatients With Type 2 Diabetes Mellitus: The Diabetes Care (D-CARE) Study
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